Manufacturing and Scale-Up of Biotechnology-Derived Products

Abstract

In the last decade, there has been a notable increase in the approval of biotechnology-based pharmaceutical products by regulatory agencies for treating various diseases. Large-scale production of these products is crucial to meet the market demand. However, the complex nature of biological techniques presents challenges in scaling up these products obtained from cell culture techniques. This chapter delves into the typical unit operations involved in the manufacturing of biotechnology-based products and the scale-up considerations required to increase the batch size. It focuses explicitly on cell culture processes and does not include fermentation processes in its discussion.